NCT01124448

Global Effects of a Probiotic Strain on Lactating Women

Oral Administration of a Probiotic to Lactating Women: Microbiological, Immunological, Transcriptomics and Metabolomics Effects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Universidad Complutense de Madrid · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

In this study, the investigators will try to confirm if application of probiotic strains isolated from breast milk actually have a beneficial effect on women suffering lactational mastitis. This project has been design to offer an integrated vision of the effects of probiotherapy (Lactobacillus salivarius PS2) on the human host. Therefore, the investigators propose a multidisciplinary approach involving the application of microbiological, immunological, genomic, metagenomic, transcriptomic and metabolomic techniques. The hypothesis is that probiotherapy will cause different effects on the host, and the objective is the finding of markers that may support the beneficial effect of the strain in such condition.

Conditions

• Mastitis

Interventions

Type	Name	Description
BIOLOGICAL	Lactobacillus salivarius PS2	9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days
BIOLOGICAL	Lactobacillus salivarius PS2	9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-09-01
• Completion: 2013-12-01
• First posted: 2010-05-17
• Last updated: 2014-08-20
• Results posted: 2014-08-20

Locations

1 site across 1 country: Spain